➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Merck
Boehringer Ingelheim
McKesson
Johnson and Johnson

Last Updated: June 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021127


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021127 describes OPTIVAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. Additional details are available on the OPTIVAR profile page.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 021127
Tradename:OPTIVAR
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 021127
Tradename Dosage Ingredient NDA Submissiondate
OPTIVAR SOLUTION/DROPS;OPHTHALMIC azelastine hydrochloride 021127 2006-12-13

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 22, 2000TE:RLD:Yes

Expired US Patents for NDA 021127

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000   Start Trial   Start Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Johnson and Johnson
Merck
McKesson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.